510(k) K082817

PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M by Primus Sterilizer Company, LLC — Product Code FLE

K082817 is an FDA 510(k) premarket notification submitted by Primus Sterilizer Company, LLC for the device "PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M". The FDA issued a decision of Substantially Equivalent on May 21, 2009. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Primus Sterilizer Company, LLC has at least 3 other 510(k) clearances on record.